MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 SENSICA UO MONITOR ICU; SENSICA DEVICE

Model Number SCCS1002

Device Problems Material Twisted/Bent (2981); Device Handling Problem (3265)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 03/01/2022

Event Type  malfunction  

Event Description

It was reported that the screen of the sensica device had been bent backwards and broken off housing.

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.

Event Description

It was reported that the screen of the sensica device had been bent backwards and broken off housing.

Manufacturer Narrative

The reported issue was confirmed.The root cause of the reported issue was that the user let bed down on unit.The device was evaluated upon receipt.Upper head assembly bent back.Replaced rear housing interface.Final functional testing completed.The device did not meet specifications, and was influenced by the reported failure.It is unknown if the device was in use on a patient.Dhr is not required as the reported event is a use-of-device failure and therefore the reported event is not manufacturing related.The instructions for use were found adequate and state the following: "stop: ensure that the bd sensica¿ urine output system is not under the patient¿s bed prior to lowering bed to prevent damage.Lower the bed when adjusting the patient position to allow extra slack in the drainage tubing, minimizing the chance of tugging the tubing out of the tube holder.For turning the patient, it may be easier to remove the bag and tubing from the system.First, lift tubing to deposit any urine in the drainage tubing into the bag, and allow the urine output volume to be recorded.Then remove the tubing and bag and hang on the patient bed.Ensure that the bag is always kept below the patient¿s bladder.After turning the patient, if needed, move the system using the crossbar handle and re-setup the system by rehanging the bag and inserting the tubing into the tube holder window.Allow the system to re-stabilize." the actual/suspected device was evaluated.

• Brand Name: SENSICA UO MONITOR ICU
• Type of Device: SENSICA DEVICE
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer (Section G): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer Contact: juan velez ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 13889515
• MDR Text Key: 288118774
• Report Number: 1018233-2022-01546
• Device Sequence Number: 1
• Product Code: EXS
• UDI-Device Identifier: 00801741215773
• UDI-Public: 00801741215773
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SCCS1002
• Device Catalogue Number: SCCS1002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/01/2022
• Initial Date FDA Received: 03/24/2022
• Supplement Dates Manufacturer Received: 09/03/2022
• Supplement Dates FDA Received: 09/12/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other